Effect of Preemptive Clonidnine versus Pethidine and Ketamine on Postoperative Shivering in addicted patients during Spinal Anesthesia in elective orthopedic surgery
The aim of the study is to compare the effect of preemptive clonidine, ketamin and pethidine in controlling postoperative shivering in addicted patients who undergo spinal anesthesia. In a clinical trial, 81 patients candidate for elective orthopaedic surgery for lower limb are enrolled and randomly assigned to groups of 27 members. Randomization is performed using random numbers generated by the computer. Exclusion criteria are massive blood transfusion; psychiatric disorders; hypothermia (t <36) or hyperthermia (t>38). Clonidine 0.2 mg is administered orally prior to surgery. Ketamin 2mg/kg and pethidine 0.5 mg/kg are administered through surgery to the patients. Postoperative shivering will be measured in patients during staying in post anethesia care unit. Blood pressure and heart rate will be recorded during 30 minutes after spinal anethesia in operating room.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042333615N1
Registration date:2017-06-30, 1396/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Mahshid Ghasemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 5454
Email address
mahshidghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Preemptive Clonidnine versus Pethidine and Ketamine on Postoperative Shivering in addicted patients during Spinal Anesthesia in elective orthopedic surgery
Public title
Control of shivering after surgery in addicted patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I to II; age between 20 to 60 years; BMI less than 30 kg/m2; scheduled for elective lower extremity surgery.
Exclusion criteria: History of hyper or hypothyroidism; Parkinson’s disease; massive blood transfusion; psychiatric disorders; hypothermia<36 or hyperthermia>38; alcoholism; tremor
Age
From 18 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was done using computer generated numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak st, Tehran, Iran
City
Tehran
Postal code
15683287
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
C/1392/1146
Health conditions studied
1
Description of health condition studied
Post operative shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-operative shivering
Timepoint
0,5,10,15,20 minutes in recovery room
Method of measurement
Asking and observing patient
Secondary outcomes
1
Description
systolic and diastolic blood pressure
Timepoint
0.5, 10, 15 and 20 minutes after surgery in recovery room
Method of measurement
monitoring
2
Description
Postoperation pulse oxymetery
Timepoint
0.5, 10, 15 and 20 minutes after surgery in recovery room
Method of measurement
monitoring
3
Description
heart rate
Timepoint
0.5, 10, 15 and 20 minutes after surgery in recovery room
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group A: Ketamin 2mg/kg is administered during surgery to the patients.
Category
Treatment - Drugs
2
Description
Intervention group B: Pethidine 0.5 mg/kg is administered during surgery to the patients
Category
Treatment - Drugs
3
Description
Intervention group C: Clonidine 0.2 mg is administered orally prior to surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Mahshid Ghasemi
Street address
no.20 , Velenjak St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaee
Street address
Velenjak St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahshid Ghasemi
Position
assistant professore
Other areas of specialty/work
Street address
Taleghani Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Fax
Email
mahshidghasemi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Mahshid Ghasemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Velanjak Sq, Tehran, Iran
City
Tehran
Postal code
15683287
Phone
+98 21 2243 2588
Fax
Email
mahshidghasemi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital, Velenjak St
City
Tehran
Postal code
Phone
+98 21 2243 2588
Fax
Email
mahshighasemi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)